Global Process Owner, PQ Reporting

Johnson & Johnson•Titusville, NJ

2d•Hybrid

About The Position

We are searching for the best talent for Global Process Owner (GPO), Product Quality Reporting to join our Innovative Medicine Quality organization. This role provides end-to-end ownership, governance, and strategic direction for Biological Product Deviation Reporting (BPDR), Field Alert Reporting (FAR), Annual Product Review (APR), and Product Quality Review (PQR). The role establishes a single, sustainable operating framework that connects regulatory reporting, periodic product review, product-risk insight, and Quality governance across the product lifecycle. Working through a global matrix, the GPO drives compliant and consistent process execution, clear decision rights, standardized data and analytics, digital enablement, process performance, inspection readiness, and continuous improvement. The role partners with sites, Platform Quality, Enterprise Quality, Regulatory, IM Regulatory Compliance, product and process owners, technology teams, and other stakeholders while execution remains with the accountable business and site organizations.

Requirements

A minimum of a Bachelor's degree is required. Degrees in pharmacy, chemistry, engineering, life sciences, statistics, or a related discipline preferred.
At least 12 years of relevant experience in the pharmaceutical, biotechnology, medical-device, or similarly regulated industry, including substantial Quality Assurance and/or Regulatory Compliance experience.
Demonstrated knowledge of global GxP and cGMP requirements and experience translating requirements into sustainable global processes and controls.
Experience leading complex, global, cross-functional programs or Quality System processes in a matrix environment.
Experience identifying and managing GxP compliance risk, including development of risk-based remediation strategies and concise reporting of risk and status.
Strong analytical, decision-making, influencing, negotiation, written, and verbal communication skills.
Demonstrated ability to define strategy and translate it into executable plans, governance, measures, and sustained change.
Ability to connect across a large, diverse organization and manage multiple priorities with sound judgment and urgency.

Nice To Haves

Advanced scientific, engineering, regulatory, data/analytics, or business degree.
Direct experience with BPDR, FAR, APR, PQR, product-quality surveillance, continued process verification, health- authority reporting, or related product lifecycle processes.
Experience as a Global Process Owner, business process owner, product owner, or Quality System owner.
Experience with global process standardization, digital workflow enablement, data governance, analytics, and inspection-ready reporting.
Experience supporting GxP audits and health-authority inspections.
Working knowledge of quality-risk-management and quality-management-system principles.

Responsibilities

Global process ownership: Own the end-to-end BPDR/FAR and APR/PQR process architecture, governance, standards, and lifecycle for IM. Establish clear scope, decision rights, roles and responsibilities, interfaces, controls, escalation pathways, and execution expectations.
BPDR/FAR governance and filing decisions: Provide global process leadership for BPDR and FAR. Establish the governance and decision framework needed to support timely, consistent, traceable, and compliant assessments and filings. Serve as, or formally designate through approved governance, the ultimate process-level filing decision authority, consistent with applicable procedures and delegated accountability.
APR/PQR governance: Act as the global process owner for the end-to-end Product Quality Review / Annual Product Review process. Set direction for sustainable global execution, including data gathering, holistic product review, interpretation of data and trends, risk identification, reporting, review, approval, and follow-through on improvement opportunities.
Integrated product-quality insight: Connect signals and outputs across BPDR/FAR, APR/PQR, complaints, investigations, NC/CAPA, escalation, continued process verification, stability, and other relevant inputs to strengthen proactive product-risk identification and management.
Standardization and simplification: Drive one globally consistent process framework while defining the controls needed for justified local or regulatory variation. Simplify workflows, reduce ambiguity, improve traceability, and clarify handoffs among global, regional, platform, site, and functional teams.
Metrics, management review, and effectiveness: Define, maintain, and analyze process KPIs and quality/compliance metrics, including timeliness, status, quality of execution, trends, recurring issues, and effectiveness. Ensure meaningful process insights are available for the appropriate management-review and Quality governance forums.
Digital, data, and analytics enablement: Own business requirements and end-to-end data governance for enabling systems, automation, analytics, and reporting. Partner with Digital Quality & Innovation and technology teams to support a coherent digital Quality ecosystem and reliable, inspection-ready data.
Community, capability, and change: Lead the global Community of Practice and process-owner network. Build process capability through guidance, learning, communications, role clarity, knowledge sharing, and structured adoption of process and technology changes.
Inspection and audit readiness: Maintain process inspection readiness; support health-authority inspections and audits; ensure timely responses to observations or process gaps; and translate internal and external insights into sustainable improvements. Monitor and influence evolving regulatory requirements.
Risk-based continuous improvement: Monitor process performance and emerging requirements, prioritize improvements based on compliance and business risk, sponsor remediation when needed, and verify that changes deliver sustained effectiveness.
Matrix leadership and stakeholder partnership: Lead globally dispersed contributors and influence across functions without reliance on direct authority. Partner with process executors and content owners to enable sound decisions while preserving clear accountability for execution and product decisions. Foster stakeholder alignment with Value Chain Management (VCM) and MSAT to create the network to have aligned input, evaluations and build culture to improve product and processes.
People and resource leadership: Where applicable, lead employees and contractors, set priorities, manage performance and development, and ensure resources and capabilities are aligned to the highest-risk and highest-value process needs.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year